Head and Neck Cancer Clinical Trial
Official title:
Lymphoscintigraphy Assisted Molecular Staging of Head and Neck Cancer
RATIONALE: New imaging procedures such as lymphoscintigraphy may improve the ability to
detect the spread of mouth and throat cancer to lymph nodes in the neck.
PURPOSE: Pilot study of lymphoscintigraphy followed by sentinel lymph node mapping and
sentinel lymph node biopsy to detect lymph node metastases in the neck in patients who have
mouth or throat cancer.
OBJECTIVES:
- Evaluate the sensitivity of lymphoscintigraphy and isosulfan blue in localization of
sentinel lymph nodes in patients with previously untreated squamous cell carcinoma of
the oral cavity or oropharynx.
- Determine evidence of micrometastases in histologically normal sentinel lymph nodes
resected from these patients.
- Assess the clinical significance of micrometastases in lymph nodes resected from these
patients.
OUTLINE: Patients undergo preoperative lymphoscintigraphy utilizing technetium Tc 99m sulfur
colloid followed by intraoperative injections of isosulfan blue at 3-4 locations into the
primary tumor periphery. Once the afferent lymphatic channel and sentinel node have been
identified, patients undergo cervical lymphadenectomy followed by resection of the primary
tumor.
Resected primary tumor, radioactive lymph nodes, and blue-stained sentinel nodes are then
subjected to molecular (polymerase chain reaction) and histocytochemical
(immunohistochemistry for cytokeratin and micrometastases, light microscopy) analyses.
Patients are followed at 1, 3, 6, 12, 18, and 24 months.
PROJECTED ACCRUAL: Approximately 25 patients will be accrued for this study.
;
Primary Purpose: Diagnostic
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